ASEAN-PPWG by Yuppadee JAVROONGRIT, Ph.D Yuppadee JAVROONGRIT, Ph.D Yuppadee JAVROONGRIT, Ph.D Yuppadee JAVROONGRIT, Ph.D. . . Co-Chair of ACCSQ/PPWG, ASEAN Regional Update on ICH-related Matters ASEAN PPWG Yuppadee – 8Jun2010, Tallinn, Estonia 1 Co-Chair of ACCSQ/PPWG, ASEAN Drug Control Division, ThaiFDA, Thailand The ICH-Global Cooperation Group Meeting Sokos Viru Hotel, Tallinn, Estonia 8 June 2010
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ASEAN-PPWG ASEAN PPWG - ICH Official web site · ASEAN-PPWG - Brunei Darussalam - Cambodia - Indonesia - Lao PDR ASEAN Member = Association of Southeast Asian Nations Yuppadee –
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- establishment ���� 8 August 1967- population ���� ~ 580 mil. (8.7% of world pop.)
- area 4.5 mil.Km2
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- area ���� 4.5 mil.Km2
- combined nominal GDP ���� >1.5 trillion USD
ASEAN-PPWG
• Objective :(i) accelerate the economic growth, social progress, and
cultural development(ii) promote regional peace and stability
• 1995 – ASEAN Leaders reaffirmed that :
The ASEAN (1)
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• 1995 – ASEAN Leaders reaffirmed that :“Cooperative peace and shared prosperity shall be the Fundamental goals of ASEAN”
ASEAN-PPWG
The ASEAN (2)
• Fundamental principle :(i) Mutual respect for the independence, sovereignty,equality
territorial integrity, and national identity of all nations(ii) The right to lead its national existence free from external
interference, subversion, or coercion
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interference, subversion, or coercion(iii) Non-interference in the internal affairs of one another(iv) Settlement of differences or disputes by peaceful manner(v) Renunciation of the treat or use of force, (vi) Effective cooperation among themselves
ASEAN-PPWG
The ASEAN (3)
• Structure and Mechanisms
ASEAN Ministerial Meeting
ASEAN Summit
Yuppadee – 8Jun2010, Tallinn, Estonia 8
Senior Officials Committees
Technical Working Groups
ASEAN-PPWG
The ASEAN (4) - Major Cooperation
ASEAN Summit
- Economic Cooperation-AEM - Political & Security Cooperation
The Leader (Presidents, Prime Minister)
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- Economic Cooperation-AEM - Political & Security Cooperation
- Socio-cultural CooperationMinister of Economic/Trade Ministry
Minister of Foreign Affairs Ministry
ASEAN-PPWG
ASEAN Summit
AEM
SEOM
ACCSQ
WGs PWGs
HLTF
The ASEAN (5) – Economic Cooperation
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WGs PWGsWG1 on Mutual Recognition Arrangements (MRAs) & Standards –
WG2 on on Accreditation and Conformity Assessment –Scientific/Industrial Metrology Sub-WG –
-ACC (ASEAN Committee on Cosmetic)
-PPWG (Pharmaceutical PWG)- EE PWG (Electrical and Electronic PWG)- Pf PWG (Prepared Foodstuff PWG)-TMHS PPWG (Traditional Medicine & Health Supplement PWG)- Medical Devices&Equipment PWG- A PWG (Automotives PWG)- RB PWG (Rubber-based PWG)- WB PWG (Wood-based PWG)
“To increase the ASEAN region’s competitive advantageas a single production unit”
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as a single production unit”
• target function ���� tariff, TBT, and NTB
ASEAN-PPWG
• the 9th ASEAN Summit :���� on 7 Oct. 03���� signed the Bali Concord II���� mandated timeline for AEC to be by the year 2020
(timeframe is re-set to “2015”)
The ASEAN (7) –the AEC (ASEAN Economic Community) (i)
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���� endorsed HLTF/ AEM’s recommendation :-- improving of the Dispute Settlement Mechanism- establishing 3 new units : Legal unit, ACT, and ACMB(or ACB now)
ASEAN-PPWG
• the Bali Concord II :���� declared the establishment of ASEAN Community���� ASEAN Community shall be comprised of 3 pillars :-
6. on going tasks ;- MRA – BA/BE Testing- Variation guideline- updating the Technical guidelines - training activities- new area of harmonization i.e. biosimilar(?)…..